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Cra Ii- Immunology/ Rheumatology (Kansas, Missouri, Indiana Or Ohio)

0-2 years
$62,000 to $126,100
10 Dec. 22, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Research Associate II
Company: Syneos Health®


About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization, committed to accelerating customer success by translating unique clinical, medical, and commercial insights into impactful outcomes. We aim to simplify and streamline processes to make Syneos Health easier to work with and for. Our Clinical Development model keeps the customer and patient at the center of everything we do.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll work alongside passionate problem solvers to innovate and help our customers achieve their goals. We are driven to accelerate the delivery of therapies, changing lives in the process.


Why Syneos Health?

  • Career Development: A culture of continuous learning, supported by career development programs, technical training, and mentorship.
  • Inclusive Environment: Emphasis on the Total Self culture, where diversity of thoughts, backgrounds, and perspectives are celebrated.
  • Global Impact: Work with 29,000 employees across 110 countries, impacting patient lives and advancing the future of biopharmaceuticals.

Key Responsibilities:

  • Site Monitoring and Management: Perform site qualification, initiation, interim monitoring, and close-out visits, ensuring regulatory compliance (ICH-GCP, GPP) and protocol adherence. Provide recommendations for site-specific actions based on performance evaluations and escalate serious issues as needed.
  • Informed Consent and Data Integrity: Verify that informed consent is adequately obtained and documented, and assess site-related risks such as protocol violations and pharmacovigilance concerns.
  • Clinical Data Review: Review site source documents and medical records, verify data entered in CRFs, and resolve queries in a timely manner. Ensure compliance with electronic data capture requirements.
  • Investigational Product Management: Ensure proper inventory, reconciliation, and storage of investigational products (IP), verifying that they are dispensed according to the protocol.
  • Documentation and Compliance: Maintain accuracy in the Investigator Site File (ISF) and Trial Master File (TMF), ensuring compliance with local regulations for document archiving.
  • Project Management: Understand project scope, budgets, and timelines, managing site-level activities to meet deliverables.
  • Training and Liaison: Act as primary liaison with study site personnel and ensure proper site training in line with project requirements.
  • Audit and Readiness: Support audit preparation and ensure compliance with audit readiness standards.
  • Real World Late Phase (RWLPS) Responsibilities: For RWLPS, manage site support throughout the study lifecycle, including data collection and chart abstraction, collaborating with local country staff and affiliates, and suggesting potential sites based on local knowledge.

Qualifications:

  • Education: Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
  • Experience: Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.
  • Skills: Strong computer skills and ability to embrace new technologies. Excellent communication, presentation, and interpersonal skills.
  • Travel: Ability to manage required travel of up to 75%.

Compensation and Benefits:

  • Salary: The annual base salary for this position ranges from $62,000 to $126,100, depending on qualifications and experience.
  • Benefits: Includes company car or car allowance, health benefits (medical, dental, vision), 401k with company match, Employee Stock Purchase Plan eligibility, commissions/bonus potential, flexible paid time off, and sick time.
  • Work-Life Balance: Syneos Health promotes a healthy work-life balance and supports employee growth and well-being.

Additional Information:

  • The company reserves the right to modify duties and responsibilities as needed.
  • Syneos Health complies with all applicable federal, state, and municipal paid sick time requirements.
  • This position may require employees to comply with vaccine requirements as mandated by local governments or customers.

Join Syneos Health today and help shape the future of biopharmaceuticals while making a difference in patient lives!